Home Stimulation for Brain-Asphyxiated Infants

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ClinicalTrials.gov Identifier: NCT00006516

Recruitment Status
:
Completed

First Posted
: November 22, 2000

Last Update Posted
: September 26, 2016

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This study examines the potential benefits of a home stimulation program to treat infants who have suffered from brain asphyxiation (lack of oxygen). The program involves one year of stimulatory activities. Progress will be evaluated through neurological and behavioral exams.

Condition or disease

Intervention/treatment

Phase

Hypoxia, BrainHypoxia-Ischemia, Brain

Behavioral: Infant stimulation

Phase 2

Detailed Description:

Although the incidence of brain injury in infants is only 2 to 5 per 1000 births, the legal and medical costs, the developmental delays, and the impact on the family are profound. Twenty to 30% of survivors of brain injury have some long-term neurologic sequelae.

This randomized controlled trial will enroll 120 term and near-term neonates with a history of asphyxia to 1-year of a standard follow-up program (provided by the Los Angeles Regional Centers) or a home-based intervention program (Utah State University's Developmental Curriculum and Monitoring System, CAMS). The experimental intervention will include individualized cognitive/neuromotor stimulation given by the child's parents under the guidance of public health nurses. Following the intervention, measures will be used to determine functional capacity (Bayley II scale and neurologic examination), behavioral outcomes (HOME and NCAST by developmental specialists), and maternal outcomes (including parent-infant interaction and perceived stress). Infants will be assessed after the 1-year intervention by psychologists and physicians masked to the intervention. Functional MRI brain studies will be conducted at discharge and 18 months of age at UCLA to assess qualitative and quantitative sensorimotor representation. Secondary outcomes include care stress and social support as reported by parents, and demographics and medical factors obtained from the hospital records.

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Ages Eligible for Study:

up to 1 Month (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

All of the following criteria must be met:

Gestation age (GA) at birth >= 28 weeks

Discharged to home care with parent or other guardian who has legal authority to give informed consent

Greater than 10th percentile for GA at birth using the scales according to Lubchenco, Hansman, and Boyd from Pediatrics 1966 volume 37 and Battaglia and Lubchenco in the Journal of Pediatrics 1967 volume 71

Infants requiring extracorporeal membrane oxygenation (ECMO) in the neonatal period

Hearing or visual impairment

Congenital cyanotic heart disease with cyanosis and requiring PGE infusion. Children with minimum cardiac structural anomalies (e.g., PDA or VSD or peripheral pulmonary stenosis) will not be excluded from the study.

Congenital abnormalities of the central nervous system such as congenital hydrocephalus

Any infant who in the opinion of investigator has no potential to benefit from the intervention (e.g., children with prenatal herpes meningitis, severe cortical destruction, mother does not follow up with the intervention or with the follow-up appointments)